Phase 2
N=176
Video-assisted Thoracoscopic Surgery - Exparel Study
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT04864210 ↗Enrolled (actual)
176
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Number of Subjects With Post-operative Opioid Usage — 42; 58 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Liposomal bupivacaine (Drug); Bupivacaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nada Sadek
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Post-operative Opioid Usage |
42; 58 | — |
| SECONDARY Measure Lung Function |
1016; 967 | — |
| SECONDARY Measure Post-operative Opioid Consumption Following Discharge From the Hospital |
1; 2 | — |
| SECONDARY Post-operative Numerical Rating Scores After Discharge From the Hospital |
0.53; 0.77 | — |
| SECONDARY Post-operative Acute Pain Numerical Rating Scores |
6; 7 | — |
Summary
Video-assisted thoracoscopic surgery (VATS) greatly decreased the number and types of surgery that required open thoracotomy. Initially it was thought that VATS would lead to a reduction of respiratory problems and less acute pain in patients when compared to patients receiving an open thoracic surgery. However, for reasons not clearly understood, a large number of patients who undergo VATS still experience moderate to severe post-surgical pain. Physicians are still faced with the challenge of providing care that will manage both the respiratory issues as well as manage acute pain. The goal of this study is to find the most suitable regimen to effectively manage post-VATS-related pain.
Eligibility Criteria
Inclusion Criteria
- Age over 18 years and less than 80 years
- Undergoing video-assisted thoracoscopic surgery (VATS) procedure
- BMI less than 40
Exclusion Criteria
- Unable to provide informed consent
- Non-English speaking
- Pregnant
- BMI greater than 40
- Video-assisted thoracoscopic surgery pleurodesis subjects
- Patients with pre-existing chronic pain
- Opioid tolerance
- Pain syndromes including fibromyalgia, regional pain syndrome or post therapeutic neuralgia in a thoracic distribution
- Allergy to the study medication
- Patients with infectious disease
- Patients with impaired coagulation
- Severe hepatic disease
- Incarcerated
Data sourced from ClinicalTrials.gov (NCT04864210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.